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Intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer

4. juni 2026 opdateret af: Silvia Corchón Arreche, University of Valencia

Multimodal Intervention to Reduce Unwanted Loneliness and Improve the Living With Process Among Family Caregivers of People With Alzheimer's Disease

The absence of social relationships negatively affects physical, psychological, and social health. In other words, it alters people's quality of life and makes active aging difficult. The investigators have designed a study to reduce unwanted loneliness and improve the living with process of family caregivers of people with Alzheimer disease through multiple interventions (music therapy, health education)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This project proposes a multimodal and interdisciplinary intervention aimed at alleviating or reducing unwanted loneliness and improving the living with process of family caregivers of individuals with Alzheimer's disease (AD). In doing so, it seeks to enhance their health and overall quality of life. The intervention will include activities such as health education, physical activity and music therapy.

The interdisciplinary team will also incorporate citizen participation, specifically through the involvement of an individual who has previously been a family caregiver of a person with AD. There is a growing body of evidence indicating that citizen participation in healthcare is highly advisable, as it is expected to improve the quality and relevance of outcomes (Kirby et al., 2024).

This is a prospective, longitudinal, analytical, and experimental study.

The proposed study will involve different groups and the program will last for a total of 12 weeks. The program will include the following activities:

Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.

Health education workshops. A total of 12 workshops. These will include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, Alzheimer disease, among others.

Music therapy workshops. Through listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance, the enjoyment and expression of feelings will be encouraged. There will be 1 session per week. Total 12 sessions

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
    • Valencia
      • Valencia, Valencia, Spanien, 46010
        • University of Valencia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Family caregivers of people with Alzheimer's disease (AD).
  • Primary family caregivers who live with the person with AD.
  • The person with AD must be enrolled in one of the adult day care centers where the study is conducted.
  • Ability to communicate in Spanish and/or Valencian.

Exclusion Criteria:

  • Presence of moderate or severe cognitive impairment, mental disorder, significant sensory impairment, disabling chronic illness, or any medical condition that contraindicates participation in any of the study activities.
  • Family caregivers of institutionalized individuals.
  • Family caregivers of people with AD who have died.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group

The multimodal interventions includes:

  1. Behavioral: Health education for family caregivers of patients with Alzheimer disease with unwanted loneliness Twelve health education workshops will be carried out. These include group training talks on the following topics: sleep hygiene, diet, and cognitive stimulation, among others.
  2. Behavioral: Music therapy for community-dwelling individuals with unwanted loneliness Description: Music therapy workshops will implemented. The enjoyment and expression of feelings will encouraged by listening to songs, singing, dancing, guided relaxation with music, and group instrumental performance. One session per week. Total 12 sessions
  3. Behavioral: Physical exercise adapted to the physical conditions of each participant. Total of 12 sessions.
Adfærdsmæssigt: Multimodal intervention to Reduce Unwanted Loneliness in Family Caregivers of People With Alzheimer

The multimodal intervention will include these activities:

  1. Health education workshops
  2. Music therapy sessions
  3. Physical exercise adapted to the physical conditions of each participant.
Ingen indgriben: No intervention group
This group will receive the ussual care in the day centers for familiar caregiver

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Score on the Jong Gierveld Lonelinss Scale
Tidsramme: From the beginning of the enrollement until the end of the intervention at 12 weeks

Loneliness Scale Social isolation will be measured with the Jong Gierveld Loneliness Scale.

The final score is the total score for the 11 items, with the lowest possible score being 0 (no loneliness) and the highest being 11 (severe loneliness). Three categories have been proposed based on the score: a score of 0-2 points = no loneliness; a score of 3-8 points = moderate loneliness; and a score of 9-11 points = severe loneliness.
From the beginning of the enrollement until the end of the intervention at 12 weeks
Living with chronic conditions from the family perspective
Tidsramme: From the enrollment to the end of the intervention at 12 weeks
Living with LTCs scale from the perspective of the family caregiver (EC- PC- Fam). This is an instrument adapted from the original EC- PC.29-31 The adaptation process of the instrument and prior pilot study have been previously described in detail.23 The validated version has 31 items and 5 domains: (1) acceptance, (2) coping, (3) self- management, (4) integration and (5) adaptation. All the items follow a Likert scale of 5 points answer system, from never or none (0) to always and much (4), except for the items from the acceptance domain, which must be inverted to obtain results such as never or none (4) or always or much (0). The scores range from 0 to 155, with a higher score indicating more positive living with LTCs.
From the enrollment to the end of the intervention at 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Score in Goldberg Anxiety and Depression Scale.
Tidsramme: From enrollement until the end of the intervention ar 12 weeks

The symptoms of anxiety and depression will be measured with the Goldberg Anxiety and Depression Scale.

This is a questionnaire that discriminates between the diagnosis of anxiety and depression and measures their retrospective intensities. It consists of two subscales: one for anxiety and one for depression. Each subscale is composed of 9 dichotomous response items (YES or NO) to determine whether the subject has had any of the indicated symptoms in the last two weeks. The cut-off points are 4 or more items or affirmative responses for the anxiety scale and 2 or more for the depression scale. The higher the score, the greater the severity of the problem, with a maximum possible score of 9 points for each subscale.
From enrollement until the end of the intervention ar 12 weeks
The score in the EuroQQL-5
Tidsramme: From enrollement until the end of the intervention at 12 weeks
The EuroQOL- 5 Dimensions 5- Level version (EQ- 5D- 5L) is an instrument designed to generically measure HRQOL, which can be used by both a healthy population and an individual with pathologies. The instrument developed by the EUROQOL group32 has been validated in many countries, including Spain.33 34 Different versions can be found, and in the present study, the EQ- 5D- 5L was selected due to the increase in the specificity of the responses as compared with the EQ- 5D- 3L. It is a self- administered instrument in which individuals assess their own health, first in a descriptive manner for each of the dimensions (mobility, personal care, everyday activities, pain/ discomfort and anxiety/depression), with five levels, from 0 to 5, and then with a more general Visual Analogical Scale. For the Spanish context, the psycho metric properties of the EQ- 5D- 5L scale were analysed in patients35 with the results indicating a reliability of 0.86.
From enrollement until the end of the intervention at 12 weeks
Score in Zarit Test for caregiver burden
Tidsramme: From enrollement until the end of the intervention at 12 weeks
Zarit test: This scale is included to verify the external validity (divergent validity) of the EC- PC- Fam. This scale, originally named Caregiver Burden Interview, is designed to assess the burden of caregivers of indi viduals with dementia, from the general theory of the items39. It has 22 items that evaluate the negative repercussions on specific areas of daily life associated with caregiving: physical health, psychological health, social activities and economic resources. As opposed to the original, the version validated in Spain40 includes a 5- point Likert scale, for a total score that ranges from 22 to 110. In this study, different cut- off points were proposed: from 22 to 46, without burden; from 47 to 55, with burden and from 56 to 110, intense burden. The scale obtained an internal consistency of 0.91 and test-retest reliability of 0.96.
From enrollement until the end of the intervention at 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Valencia

Samarbejdspartnere

The Faculty of Nursing and Podiatry, University of Valencia.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-ENFPOD-3741812

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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